Hsieh Tsung-Ta, Lee Meng, Huang Wen-Yi, Tang Sung-Chun, Sung Sheng-Feng, Chang Kuo-Husan, Lee Jiann-Der, Lee Tsong-Hai, Huang Yung-Sung, Jeng Jiann-Shing, Chung Chang-Min, Wu Yi-Ling, Ovbiagele Bruce
Department of Neurology, Chang Gung University College of Medicine, Chang Gung Memorial Hospital, Chiayi Branch, Taiwan.
Department of Neurology, Chang Gung University College of Medicine, Chang Gung Memorial Hospital, Keelung Branch, Taiwan.
Contemp Clin Trials Commun. 2017 Jun;6:127-130. doi: 10.1016/j.conctc.2017.04.005. Epub 2017 Apr 26.
Enhancing detection of undiagnosed atrial fibrillation (AF) in hospitalized patients with a recent ischemic stroke is important because of the treatment implications; especially since presence of paroxysmal AF may not be picked up in a single 12-lead electrocardiogram (ECG) test. While several trials have shown improved detection of AF with prolonged ECG monitoring, this strategy is associated with relatively high cost, labor intensity, and patient inconvenience, thereby making it challenging to routinely implement in all hospitals. Fortunately, conventional 24-h Holter monitoring and repeated 12-lead ECGs are readily available to detect paroxysmal AF in all hospitals, but is unclear which is the better strategy for evaluating undiagnosed AF. The objective of his study is to conduct a randomized trial of serial 12-lead ECGs vs. 24-hour Holter monitoring in the detection of AF in ischemic stroke patients without known AF.
We plan to enroll 1200 participants from six hospitals in Taiwan. Patients will be eligible for enrollment if they are admitted for an acute ischemic stroke within 2 days, are ≥65 years of age, and have no known AF by history or on baseline ECG at admission. We will randomly assign participants in a 1:1 ratio to undergo daily 12-lead ECG once daily for 5 days (intervention group) or 24-h Holter monitoring (control group). Primary outcome is newly detected AF on a 12-lead ECG or AF lasting ≥30 s on Holter monitoring.
ClinicalTrials.gov Identifier: NCT02578979.
提高近期缺血性卒中住院患者未诊断出的房颤（AF）的检测率很重要，因为这会影响治疗；特别是阵发性房颤可能无法通过单次12导联心电图（ECG）检测出来。虽然多项试验表明延长心电图监测可提高房颤的检测率，但该策略成本相对较高、劳动强度大且给患者带来不便，因此在所有医院常规实施具有挑战性。幸运的是，所有医院都可通过常规的24小时动态心电图监测和重复12导联心电图来检测阵发性房颤，但尚不清楚哪种策略在评估未诊断出的房颤方面更好。本研究的目的是进行一项随机试验，比较连续12导联心电图与24小时动态心电图监测在检测无已知房颤的缺血性卒中患者房颤方面的效果。
我们计划从台湾的六家医院招募1200名参与者。如果患者在2天内因急性缺血性卒中入院、年龄≥65岁且既往史或入院时基线心电图无已知房颤，则符合入选条件。我们将按1:1的比例随机分配参与者，让其接受为期5天的每日一次12导联心电图检查（干预组）或24小时动态心电图监测（对照组）。主要结局是12导联心电图新检测出的房颤或动态心电图监测中持续≥30秒的房颤。
ClinicalTrials.gov标识符：NCT02578979。
